Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Apr 11, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for patients with hepatic encephalopathy, a condition that affects brain function due to liver problems. Specifically, it is studying the safety and effectiveness of using oral capsules containing fecal microbiota transplantation (FMT) as a therapy for patients who are not responding well to standard treatments like rifaximin and lactulose. Participants will be divided into three groups: one group will receive FMT through both colonoscopy and oral capsules, another group will only take the oral capsules, and the third group will continue with their usual treatment without any additional FMT.

To be eligible for this study, patients must have liver cirrhosis and a diagnosis of hepatic encephalopathy that is persistent or comes back despite adequate treatment. They should be between the ages of 65 and 74 and not have certain medical conditions that could complicate the trial, such as severe kidney issues or other causes of brain dysfunction. Participants can expect to continue their standard therapies while receiving FMT, and researchers will monitor changes in gut health and any improvements in their symptoms. This trial is currently recruiting participants, and it aims to better understand how this new treatment might help those struggling with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of liver cirrhosis
• • Hepatic encephalopathy of grade \>1 or higher according to West Haven classification, persistent or recurrent despite treatment with lactulose/lactitol and rifaximin at adequate doses started at least 30 days before the Hepatic encephalopathy episode
• Exclusion Criteria:
• • Na \<130 meq /l
• • Creatinine \> 1.3 mg / dl
• • Presence of grade 3 ascites
• • Presence of esophagogastric varices at risk of haemorrhage in the absence of adequate prophylaxis
• • Presence of other possible causes of encephalopathy (cerebral vascular disease, known neurodegenerative or cognitive disorders)
• • Known psychiatric disorders or other causes of brain dysfunction (e.g. hypoglycemia, hyponatremia)
• • Alcohol consumption
• • Diagnosis of hepatocellular carcinoma
• • Contraindication to fecal microbiota transplantation (e.g. pregnancy or breastfeeding)
• • Presence of known intestinal diseases
• • Any clinical condition that, in the opinion of the investigators, may contraindicate the enrollment in the study